FDA WARNING_LETTER - Roundman's Smokehouse - February 27, 2014

The FDA inspected Roundman’s Smokehouse in Fort Bragg, California, on February 25 and 27, 2014, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Consequently, the firm's refrigerated vacuum packaged ready-to-eat smoked albacore tuna and sockeye salmon were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies included the failure to conduct a proper hazard analysis, specifically omitting allergens from HACCP plans (21 CFR 123.6(a) and (c)(1)). Critical limits in HACCP plans for brining were inadequate to control pathogen growth and toxin formation, including Clostridium botulinum toxin (21 CFR 123.6(c)(3)). Monitoring procedures were insufficient, lacking specific monitoring for certain parameters at critical control points, and using inadequate temperature monitoring for cooler storage (21 CFR 123.6(c)(4)). The firm also failed to take appropriate corrective actions when critical limit deviations occurred (21 CFR 123.7(a)) and had inappropriate corrective action plans that did not ensure the cause of deviation was corrected or prevent adulterated products from entering commerce (21 CFR 123.7(b)). Furthermore, sanitation conditions and practices were not monitored with sufficient frequency, specifically concerning cross-contamination, toilet facilities, and protection from adulterants (21 CFR 123.11, 21 CFR 110). The FDA requires a written response within fifteen working days detailing corrective actions and providing supporting documentation, warning of potential product seizure or operational injunction if violations are not promptly corrected.